Senior Supplier Quality Engineer, NPD

Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team.

This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers.

The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and Edwards’ systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities :

Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes / methods based on engineering principles;

analyze results, make recommendations, and develop reports.

Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles;

analyze results, make recommendations and develop reports.

Identify and ensure the optimization of complex Manufacturing and / or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.

Identify opportunities for re-design / design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Develop, update, and maintain technical content of risk management files.

Continually assess the Supplier Management and QA Management system and SOP's for continual improvement

Drive deliverables to obtain Supplier approval.

Train, coach, and guide employees on routine procedures

Required Qualifications :

Bachelor’s degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required

Domestic and International Travel upwards of 25%

Preferred Qualifications :

Experience with class II and class III medical devices

Working knowledge of International and Domestic FDA regulations

Understanding of Manufacturing processes (i.e. Injection Molding, Extrusion, and Machining)

Additional Skills :

Effective communication and conflict resolution skills

Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)

Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s

Understanding of Risk Management principles

Six Sigma Green or Black Belt / LEAN Manufacturing experience a plus

Ability to manage competing priorities in a fast-paced environment

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination.

If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.

This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.